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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06532006
Registration number
NCT06532006
Ethics application status
Date submitted
25/07/2024
Date registered
1/08/2024
Date last updated
24/08/2025
Titles & IDs
Public title
A Phase ? Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer
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Scientific title
A Randomized, Double-blinded, Multicenter, Phase ? Clinical Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab and Chemotherapy (XELOX) Versus Trastuzumab and Chemotherapy (XELOX) With or Without Pembrolizumab for the First Line Treatment of Locally Advanced or Metastatic Gastroesophageal Junction and Gastric Cancer
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Secondary ID [1]
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HLX22-GC-301
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gastroesophageal-junction Cancer
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Monoclonal Antibody
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Gastric Cancer
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HER2-positive Gastric Cancer
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Condition category
Condition code
Cancer
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Stomach
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - HLX22
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Trastuzumab
Treatment: Drugs - Oxaliplatin
Treatment: Drugs - Capecitabine
Experimental: Experimental group - Experimental group: HLX22 (15 mg/kg) + trastuzumab + chemotherapy (XELOX) ± placebo (for pembrolizumab), Q3W
Subjects in the experimental group may use one of the treatments below:
HLX22 (15 mg/kg) + trastuzumab + chemotherapy (XELOX) or HLX22 (15 mg/kg) + trastuzumab + chemotherapy (XELOX) + placebo (for pembrolizumab)
Active comparator: Control group - Control group: Placebo (for HLX22) + trastuzumab + chemotherapy (XELOX) ± pembrolizumab, Q3W
Subjects in the control group may use one of the treatments below:
Placebo (for HLX22) + trastuzumab + chemotherapy (XELOX) or Placebo (for HLX22) + trastuzumab + chemotherapy (XELOX) + pembrolizumab
Treatment: Drugs: HLX22
HLX22 15mg/kg Q3w
Treatment: Drugs: Pembrolizumab
Pembrolizumab 200mg q3w
Treatment: Drugs: Trastuzumab
Trastuzumab 8 mg/kg loading dose and then 6 mg/kg maintenance thereafter ,Q3W
Treatment: Drugs: Oxaliplatin
Oxaliplatin 130 mg/m2 ,Q3W
Treatment: Drugs: Capecitabine
Capecitabine 1000 mg/m2 bid on Days 1-14 ,Q3W
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-Free Survival (PFS)per RECIST 1.1 assessed by IRRC(Independent Radiology Review Committee)
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Assessment method [1]
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PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first. PFS will be determined for each treatment arm
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Timepoint [1]
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Up to 5 years
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Primary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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OS is defined as the time from randomization to death due to any cause. OS will be determined for each treatment arm.
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Timepoint [2]
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Up to 5 years
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Secondary outcome [1]
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PFS per RECIST 1.1 assessed by investigator
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Assessment method [1]
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PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first. PFS will be determined for each treatment arm
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Timepoint [1]
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Up to 5 years
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Secondary outcome [2]
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Objective Response Rate (ORR) assessed by IRRC and investigator per RECIST v1.1
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Assessment method [2]
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ORR is defined as the percentage of participants who have a Complete Response (\[CR\], disappearance of all evidence of disease) or Partial Response (\[PR\], regression of measurable disease and no new sites) per RECIST 1.1. ORR will be determined for each treatment arm.
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Timepoint [2]
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Up to 5 years
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Secondary outcome [3]
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Adverse events (AE)
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Assessment method [3]
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An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who experience an AE will be reported for each treatment arm.
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Timepoint [3]
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Up to 5 years
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Eligibility
Key inclusion criteria
1. Male/female who are at least 18 years of age on the day of signing the informed consent.
2. With histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
3. Had measurable disease as assessed by IRRC according to the RECIST v1.1, the target lesion must not be a bone metastatic lesion only.
4. HER2-positive tumor defined as either IHC 3+ or IHC 2+ in combination with ISH+ or FISH, as assessed by a central laboratory on a primary or metastatic tumor.
5. ECOG PS within 7 days before randomization: 0-1.
6. Expected survival = 6 months.
7. Had adequate organ function
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Patients with other malignant tumors within 2 years before the randomization.
2. Evidence of disease progression within 6 months (before randomization) after completion of prior neoadjuvant or adjuvant chemotherapy (or both) or radiotherapy for gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
3. Previous treatment with any HER2-target therapy.
4. Active gastrointestinal bleeding
5. Presence of central nervous system (CNS) metastases.
6. Left ventricular ejection fraction (LVEF) < 55%.
7. Subjects who had known history of severe allergy to any monoclonal antibody or any component of study treatment.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/11/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/09/2028
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Actual
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Sample size
Target
550
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
MelbourneQLD,Sydne
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Recruitment hospital [1]
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St. Vincent Hospital Melbourne - Fitzroy
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Peninsula Health-Frankston hospital - Frankston
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University of the Sunshine Coast Clinical Trials, Sunshine Coast Haematology and Oncology Clinic - Sunshine Coast
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GenesisCare Research - Campbelltown
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Central Coast Local Health District (Gosford and Wyong Hospital) - Gosford
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Macquarie University - North Ryde
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Concord Repatriation General Hospital - Concord
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3065 - Fitzroy
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Recruitment postcode(s) [2]
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3940 - Frankston
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Recruitment postcode(s) [3]
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4556 - Sunshine Coast
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Recruitment postcode(s) [4]
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2560 - Campbelltown
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Recruitment postcode(s) [5]
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2250 - Gosford
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Recruitment postcode(s) [6]
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2109 - North Ryde
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Recruitment postcode(s) [7]
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Sydney - Concord
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Recruitment outside Australia
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United States of America
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California
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Georgia
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Kanazawa
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Osaki-shi
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Saitama
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Sapporo
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Shanghai Henlius Biotech
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Henlius USA
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Ethics approval
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Summary
Brief summary
This is a double-blind, randomized, multiregion, comparative phase ? clinical study designed to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy as first-line treatment in patients with HER2-positive locally advanced/metastatic adenocarcinoma of the gastric and/or gastroesophageal junction (G/GEJ).Eligible subjects will be randomized to the two groups based on a 1:1 ratio. Enrolled subjects shall be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first).
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Trial website
https://clinicaltrials.gov/study/NCT06532006
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Contact person for public queries
Name
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Ying Li
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Address
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Phone
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+86 18810366427
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06532006
Download to PDF